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Pharmacy

Generic vs Branded Drugs: Understanding the Difference

To manufacture a generic drug, the manufacturer should follow Good Manufacturing Practices, use approved facilities and equipment, and prove bioequivalence to the branded drug

MBT Desk

Have you ever wondered why some medicines cost five times more than others, despite having the same effect? The answer lies in the difference between branded and generic drugs.

Introduction

When you go to a pharmacy, you may hear terms like "generic" and "branded" drugs. But what do they really mean? Understanding the difference between generic and branded drugs is important, especially when it comes to affordability, quality, and effectiveness. In this article, we'll explore how they are made, how they differ, and whether you can trust one over the other.

What are Generic and Branded Medicines

A generic drug is one that is designed to be exactly like a previously approved drug. Based on safety and efficacy data from studies on the authorised drug, its approval is anticipated.
Generic medicines can only be produced once the branded drug’s patent expires. [1]

A branded medicine, often referred to as an innovator drug or a non-generic drug, is a pharmaceutical product that is marketed under a proprietary name by the firm that created it. These businesses frequently consist of pharmaceutical firms that have made significant investments in marketing, clinical studies, and research and development in order to introduce a new prescription medication to the market. [2]

The FDA reviews the application and ensures that the generic drug is similar to the branded drug in terms of safety and efficacy.

Key Differences Between Generic and Branded Drugs

Composition and Effectiveness

Generic and branded drugs are similar in terms of active ingredients but differ in the excipients used. The drugs may also differ in terms of color, shape, size, and markings. Both generic and branded drugs are designed to have the same therapeutic effect.
Generic drugs undergo a bioequivalence study to prove their therapeutic effectiveness. [3] Bioequivalence means the generic delivers the same amount of active ingredient into a patient's bloodstream in the same time as the branded drug.

FDA reviews the application and ensures that the generic drug is similar to branded drug in terms of safety and efficacy.

Standards Required for Generic Drugs

  • Active ingredient is the same as in the branded drug

  • Have the same strength and dosage form

  • Have the same route of administration

  • Same use indications

Cost and Price

Generic drugs are less expensive than branded drugs because they do not have to undergo the same preclinical and clinical research that branded drugs must undergo to establish safety and efficacy.
Generic drugs are sold in the market with substantial discounts, making them less costly than branded drugs. [4]

Example: A branded medicine (Lipitor) may cost ₹150 per strip, while its generic version (Atorvastatin) could be just ₹30–40.

Manufacturing and Approval

To manufacture a generic drug, the manufacturer should follow Good Manufacturing Practices, use approved facilities and equipment, and prove bioequivalence to the branded drug.

Once the manufacturing of the generic drug is completed, the manufacturer submits the Abbreviated New Drug Application (ANDA) form to the FDA to grant approval for releasing the generic drug in the market. Abbreviated New Drug Application (ANDA): A streamlined FDA submission process for generics that demonstrates bioequivalence to a branded drug. [5]

The ANDA includes information on the generic drug’s composition, manufacturing process, and quality control. It also includes bioequivalence data.

You can consult with your healthcare professional to determine the appropriate treatment plan for you.

The FDA reviews the application and ensures that the generic drug is similar to the branded drug in terms of safety and efficacy.

Generic vs Brand Name Medication in India

You can consult with your healthcare professional to determine the appropriate treatment plan for you.

Examples of Generic and Branded Drugs in India

Brand NameGeneric NameTherapeutic Purpose
AdderallAmphetamine salt comboAttention Deficit Hyperactivity Disorder
GlucophageMetforminType 2 Diabetes
ZoviraxAcyclovir tabletGenital herpes
TenorminAtenolol tabletHypertension
CleocinClindamycin PhosphateBacterial Infection
EstraceEstradiol TabletMenopause symptoms
DiflucanFluconazoleFungal Infection
CrocinParacetamolPain relief, Fever
ZyrtecCetirizineHay fever
AzeeAzithromycinRespiratory Infection

How to Identify Branded vs Generic Medicines

  • Check the name of the medicine: Generic medicine has a name that doesn’t include a brand name. Generic medicine will include the name of the active ingredient with its strength. [6]

  • Compare Prices: Generic drugs are priced lower than their branded counterparts.

  • Packaging: Branded drugs are packed with unique packaging and hallmark signs, whereas generic drugs are packed in a simple, plain container.

  • Ask your Pharmacist: Provide your prescription to your nearby pharmacist, and they can help in distinguishing between branded and generic drugs.

Conclusion

When you visit a pharmacy store and see generic and branded drugs with the same active ingredient, you may get confused or have difficulty choosing the best medicine for you. But once you understand the difference between generic and branded drugs, you'll realise that both have their uses. Generics are less expensive while maintaining high quality.
You can consult with your healthcare professional to determine the appropriate treatment plan for you.

References:

  1. European Medicines Agency. “Generic Medicine.” EMA. Accessed June 4, 2025. https://www.ema.europa.eu/en/glossary-terms/generic-medicine.

  2. Adragos Pharma. “Generic vs Brand Name Drugs: Key Differences Explained.” Adragos Pharma. Accessed June 4, 2025. https://adragos-pharma.com/generic-vs-brand-name-drugs-key-differences-explained.

  3. Canadian Dental Association. “Similarities and Differences between Brand Name and Generic Drugs.” CDA. Accessed June 4, 2025. https://www.cda-amc.ca/similarities-and-differences-between-brand-name-and-generic-drugs.

  4. U.S. Food and Drug Administration. “Generic Drugs: Questions & Answers.” FDA. Accessed June 4, 2025. https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs-questions-answers.

  5. U.S. Food and Drug Administration. “Generic Drug Facts.” FDA, March 2020. https://www.fda.gov/drugs/generic-drugs/generic-drug-facts.

  6. Medkart. “How to Identify Generic Medicines in India?” Medkart Blog. Accessed June 4, 2025. https://www.medkart.in/blog/how-to-identify-generic-medicines-in-india.

By Tushali Khanna, MPharm Pharmacology 2nd Year

MSM/SE

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